Fluid dispensing device with stopper

ABSTRACT

A fluid dispensing device is disclosed having a body housing a pump action fluid discharge device having a dispensing nozzle. The fluid dispensing device comprises a body defining a cavity and a dispensing nozzle having a dispensing orifice, a fluid discharging device housed in the cavity, the fluid discharging device having a hollow casing defining a reservoir for containing a volume of fluid and a plunger slidingly engaged within the hollow casing, the plunger having a tubular portion which extends from a first end of the hollow casing for co-operation with the dispensing nozzle to enable pumped delivery of fluid from the reservoir to the dispensing nozzle, wherein the dispensing orifice of the dispensing nozzle is provided with a reversible stopper.

The present invention relates to a medicament dispenser and inparticular to a fluid dispensing device for use as a nasal inhalationdevice for delivery of medicament.

It is well known to provide a medicament dispenser, in which fluid isdispensed via a nozzle or orifice upon the application of a force by auser to a pump dispenser. Such devices are generally arranged with areservoir containing several doses in a fluid formulation to bedispensed by sequential metered pump actuations. An example of a pumpaction spray is shown and described in U.S. Pat. No. 4,946,069.

It is a problem with such prior art mechanical pumps that fluiddelivered to the nozzle or orifice but not dispensed there from mayunder normal atmospheric pressure drain back down the interior of thenozzle and potentially into the fluid reservoir. This can lead tomedicament precipitating out onto the sides of the nozzle interior andpump and also potentially to contamination of the contents of thereservoir by drained-back fluid material.

It will be appreciated that the prevention of fluid drain back istherefore desirable.

The Applicants have now found that the problem of fluid drain back maybe ameliorated by the use of a stopper placed over the dispensingorifice of the nozzle. The stopper acts to prevent the normal drainingback action by setting up a ‘negative pressure’ effect between thestoppered end and potentially draining back fluid in the nozzle tip, andthereby reduces the need to re-prime the device before the next usethereof as can be required where drain back occurs.

It is an object of the present invention to provide a fluid dispensingdevice, which provides reduced drain back of fluid from the nozzle.

It is a further object of the present invention to provide a fluiddispensing device, which prevents the need for priming (i.e. ‘re-prime’)before use, as can be required for a device that permits drain back offluid from the nozzle.

According to a first aspect of the invention there is provided a fluiddispensing device comprising a body defining a cavity and a dispensingnozzle having a dispensing orifice, a fluid discharging device housed inthe cavity, the fluid discharging device having a hollow casing defininga reservoir for containing a volume of fluid and a pump having a suctioninlet extending within the hollow casing, the pump having a dischargeoutlet extending from a first end of the hollow casing for co-operationwith the dispensing nozzle to enable pumped delivery of fluid from thereservoir to the dispensing nozzle, wherein the dispensing orifice ofthe dispensing nozzle is provided with a reversible stopper.

The stopper acts such as to prevent drain back of delivered fluid fromthe dispensing nozzle (in particular, from the area at the tip of thenozzle and generally adjacent to the dispensing orifice). The stopperalso acts such as to reduce fluid egress by evaporation as would tend tooccur at an open (i.e. unstoppered) dispensing orifice.

The stopper is reversibly mountable to the dispensing orifice of thenozzle (e.g. at the tip). That is to say, the stopper may reversibly bearranged in both a ‘storage’ position, in which it locates at thedispensing orifice to prevent drain back of fluid into the nozzle and inan ‘in use’ position, in which it is spaced from the dispensing orificeto allow dispensing of fluid from the nozzle.

In one aspect, the nozzle tip is shaped to define an essentially flatprofile. In another aspect, the nozzle aspect is shaped such as todefine a well circumferential to the dispensing orifice. Where acircumferential well is so defined, the stopper herein may be arrangedto extend at least partly into that well when the device is in the‘storage position’.

Suitably, the stopper is located on the exterior of the dispensingnozzle. That is to say, the stopper is not located and/or does notextend within the nozzle (i.e. not within the nozzle dispensingchannel).

Suitably, the stopper is independent of the fluid discharging device,and particularly the pump and/or container thereof.

It will be appreciated that in general operation of the fluid dispensingdevice relative movement between the hollow casing and the pump actssuch as to pump fluid from the fluid reservoir into the dispensingnozzle for dispensing therefrom.

In aspects, the pumping is metered. For example, each pumping actionresults in delivery of a single dose of fluid from the reservoir to thenozzle.

Suitably for metered delivery, the pump includes a plunger, which isslidable in a metering chamber located within the hollow casing, themetering chamber being sized to accommodate a single dose of fluid.

The reservoir typically contains several doses of fluid.

The stopper herein is reversibly mountable to the dispensing nozzle toenable reversible sealing of the dispensing orifice. In use, suchsealing acts such as to minimise drain back of fluid from the dispensingorifice through the interior of the nozzle.

The Applicant has found that the profile of that part of the stopperthat contacts the dispensing nozzle (i.e. stoppers the dispensingorifice) in the ‘storage position’ has a curved profile and ispreferably hemispherical (e.g. dome shaped). Such hemispherical shapehas been found to assist in locating the stopper at the dispensingorifice (or tip) for effective stoppering thereof.

The Applicant has also noted that if a stopper is used that has a flat(e.g. disc-shaped or squared off) contact profile there is a risk thatif the stopper does not align perfectly with the dispensing nozzleorifice one part of the stopper tends to tip up and another part to tipdown, thereby compromising its sealing ability. This problem does notarise in relation to the preferred hemispherical shape, which naturallytends to align the ‘crest’ of the hemisphere with the tip of the nozzle.

In one aspect, the hemispherical stopper is flexible enough such that inthe ‘storage position’ a portion of the stopper extends into thedispensing orifice of the dispensing nozzle to partly fill the spacetherein and hence to minimise any air gap.

The stopper may have any suitable overall shape including disc shaped,wherein the disc may be flat, or in aspects have a convex or concaveform.

In one preferred aspect, the stopper comprises a flat, preferablydisc-shaped base and a hemispherical head element provided thereto.Overall, the stopper therefore suitably resembles a ‘bowler hat’ withthe crest of the hat contacting the dispensing nozzle, in use to preventdrain back at the dispensing orifice. The base and head parts of thestopper may be formed separately and then brought together, oralternatively the overall ‘bowler hat’ shape (i.e. base and head) ismoulded as a single part.

It will be appreciated that the stopper is generally shaped to optimisesealing engagement with the tip of the dispensing nozzle (i.e. that areaproximal to the dispensing orifice). It also is desirable that thesealing acts such as to minimise the ‘air gap’ defined at the dispensingorifice when the device is in the ‘storage position’, preferablyreducing it to close to zero. In general terms, the ‘air gap’ is thatfree volume defined in combination by the stopper, dispensing channel ofthe nozzle and head of fluid in the dispensing channel.

Suitably, the volume of the air gap is small enough such that anypressure drop due to an increase in this volume balances the weight offluid below it to prevent the fluid draining back down into the pump.

Desirably, the seal provided by the stopper is fully airtight, althoughin practical terms where there is an initial air gap some slight seepageof air inevitably occurs over an extended time scale. The Applicant hasrealized that the volume of any air seepage through the seal isproportional to the difference in pressure between the air gap andambient atmospheric pressure. Where however, the air gap has essentiallyzero volume (i.e. the stopper contacts the fluid in the dispensingchannel such that there is no air gap) the relevant pressure differenceis that between the fluid in contact with the stopper and the atmosphereand the seepage rate through the seal is drastically reduced.

The Applicant has also realized that where an air gap exists any drainback will tend to reduce the pressure in the air gap, which in turnincreases the seepage past the seal having the result that the air gapincreases to promote even greater drain back. Thus, drain back canpromote seepage past the seal, which in turns promotes further drainback. This realization therefore provides direction to both reduce thesize of the initial air gap and to ensure maximum seal integrity by thestopper since both of these factors in tandem influence subsequent drainback and seepage through the seal.

In one aspect, the shape of the stopper, particular the part that in the‘storage position’ contacts the dispensing nozzle, may be arranged toinversely mirror that of the nozzle tip. In one particular aspect, atleast part of the stopper has concave form and is shaped to mirror theform of a convex tip of the dispensing nozzle.

In another aspect, the tip of the dispensing nozzle is either formedfrom a soft, compressible material or has soft, compressible materialprovided thereto (e.g. as a ring of material provided around the tip) toensure effective contact between the stopper and the tip of thedispensing nozzle for effective reduction of drain back at thedispensing orifice.

The stopper may be formed from any suitable material including thosewith plastic properties, particularly those with resilient properties.Stoppers made from synthetic and naturally occurring polymers includingrubber are herein envisaged.

Particular stopper materials include elastomeric materials such assynthetic rubbers and Thermoplastic Elastomer (TPE) materials, includingthose materials sold under the trade name Santoprene by AdvancedElastomer Systems, including that material sold under the trade nameSantoprene 8000 Rubber 8281-35W237.

Suitable elastomeric materials are typically employed within theirelastic regime and are preferably susceptible to injection mouldingtechniques for forming suitable stopper shapes and particularly contactprofiles (i.e. the profile of the part of the stopper that contacts thedispensing nozzle in the ‘storage position’).

Suitably, the stopper materials are soft enough to be reasonablycompressible but hard enough to retain a shape for stoppering thedispensing orifice. The Applicant has determined that stopper materialshaving a hardness of from 30 to 40 Shore A, particularly from 33 to 37Shore A, such as 35 Shore A are especially suitable.

Suitable stoppers may be formed in a variety of ways. In one aspect, arubber disc-shaped stopper is stamped from a sheet of rubber. In anotheraspect, a disc-shaped stopper is moulded (e.g. by an injection mouldingprocess).

It is envisaged that when in the ‘storage position’ the stopperexperiences a certain compressive force such as to ensure sufficientsealing contact with the dispensing nozzle to prevent drain back at thedispensing orifice. Suitably, the amount of compressive force greaterthan 1.5N, typically from 2 to 6N.

The device may further comprise a protective end cap having an innersurface for engagement with the body. The end cap is moveable from afirst position in which it covers the nozzle to a second position inwhich the nozzle is uncovered.

Suitably, the stopper locates on the end cap such that when the end capis in the first (i.e. protective) position the stopper contacts (e.g.engages) the dispensing nozzle to seal the dispensing orifice. In thesecond (i.e. in-use position) the stopper is spaced from (e.g.disengaged from) the dispensing nozzle such that the dispensing orificeis no longer sealed.

The stopper may form an integral part of the end cap or alternatively,the stopper may mount to the end cap. Any suitable method of mounting isenvisaged including adhesive, snap-fit and weld mounting. In general,the stopper locates in the inner part of the end cap.

In one aspect, the inner part of the end cap is provided with annularwalls defining a cavity for receipt of the stopper as an insert thereto.The stopper insert may be simply be mechanically inserted within saidcavity (e.g. interference fit) or it may be adhesively or otherwisefixed.

One preferred stopper insert has the ‘bowler hat’ form describedpreviously, in which the stopper insert comprises a flat, preferablydisc-shaped base and a hemispherical head element. The base of thestopper is inserted into the cavity defined by the annular walls suchthat the head faces outwards and may contact the dispensing nozzle, inuse to prevent drain back at the dispensing orifice.

Suitable stopper insert forms may be formed in a variety of ways. In oneaspect, a rubber disc-shaped stopper is stamped from a sheet of rubber.In another aspect, a disc-shaped stopper is moulded (e.g. by aninjection moulding process). In a further aspect, the protective end capis moulded and the stopper is then moulded within the formed end cap(i.e. a ‘two shot’ moulding process).

In one particular aspect, the inner part of the end cap is provided withan annular wall or walls defining a cavity for receipt of the stopper asan insert thereto and that end cap is formed as a moulding and thestopper insert is provided as a second moulding thereto (i.e. by way ofa second moulding operation in an overall ‘two shot’ moulding process).In a variation of this aspect, the material provided as in the secondmoulding operation may extend beyond the stopper to form other parts ofthe end cap (e.g. in one aspect to form a mounting for mounting the endcap to a body of the dispensing device).

In another particular aspect, the inner part of the end cap is providedwith an annular wall or walls defining a cavity for receipt of thestopper as an insert thereto and the stopper insert has a concertinaform such that it may readily compress to accommodate the form of thedispensing nozzle for effective sealing of the dispensing orifice.

In a further particular aspect, the inner part of the end cap isprovided with an annular wall or walls defining a cavity for receipt ofthe stopper as an insert thereto and the stopper insert has a rollerball form. The annular walls are thus shaped with mounting elements(e.g. arms or pins) for mounting the roller ball within the cavity. Inuse, the roller ball contacts the dispensing nozzle for effectivesealing of the dispensing orifice.

In another aspect, the inner part of the end cap is provided with anannular wall or walls protruding into the cap interior and a thin endwall provided thereto. In use, the thin end wall contacts the dispensingnozzle tip and thereby acts as a stopper to prevent drain back at thedispensing orifice. The annular wall or walls may either be rigid orflexible (e.g. susceptible to flexing in concertina-fashion). The thinwall is typically flexible such that it may accommodate the form of thedispensing nozzle tip for effective sealing of the dispensing orifice.In embodiments, a plug is provided to fit in the cavity defined by theannular walls and end wall to prevent damage thereto.

The end cap is suitably arranged for guided receipt by the body, inparticular to ensure best alignment of the stopper and dispensingorifice of the nozzle in the ‘storage position’. The end cap may inparticular, be provided with guide projections (e.g. legs) arranged forreceipt by apertures and/or channels defined within the body andarranged for correct alignment of end cap with body. In aspects, theprojections include lugs or other retaining means for reversiblyretaining the end cap to the body.

The Applicant has however, noted that screw engagement of the end capwith body can be problematic in that the screw action may result infrictional contact between the stopper insert of the end cap and thedispensing nozzle that may cause the stopper insert to become detachedfrom the end cap.

The end cap is suitably formed from a rigid material and one that doesnot tend to creep during its lifetime. A suitable end cap material isthat sold under the trade name Terluran GP-22 Natural by BASF Plastics.

The hollow casing may take any suitable form. Suitably, several lugs areformed on the hollow casing for engagement with complementaryprojections formed on the inner surface of the end cap, each of the lugsbeing arranged to extend through a longitudinally extending slot formedin the side wall of the body.

The hollow casing may have at least one outwardly extending detent forengagement with a complementary recess formed in the inner surface ofthe end cap so as to releasable hold the end cap in position on thebody.

Each detent may extend through a respective longitudinally extendingslot in the body for engagement with the respective recess formed in theend cap.

In one aspect, the fluid discharging device is moveably housed withinthe housing, the fluid discharging device having a longitudinal axis andthe fluid dispensing device is provided with finger operable meansmoveable with respect to the longitudinal axis of the fluid dischargingdevice to apply a force to the container to move the container along thelongitudinal axis towards the nozzle so as to actuate the compressionpump.

The term finger operable means is meant to encompass such means operableby action of the finger or thumb, or combinations thereof of a typicaluser (e.g. an adult or child patient).

In one aspect, the finger operable means is moveable transversely withrespect to the longitudinal axis of the fluid discharge device to applya force directly or indirectly to the container. In another aspect, thefinger operable means is moveable generally parallel to the longitudinalaxis of the fluid discharge device to apply a force directly orindirectly to the container. Other movements intermediate between‘transverse’ and ‘parallel’ are envisaged. In variations, the fingeroperable means may contact the container or be coupled thereto to enablethe necessary transfer of force.

Suitably, the finger operable means is arranged to apply mechanicaladvantage. That is to say, the finger operable means applies mechanicaladvantage to the user force to adjust (generally, to enhance or smooth)the force experienced by the container. The mechanical advantage may inone aspect, be provided in either a uniform manner such as by a constantmechanical advantage enhancement, for example by a ratio of from 1.5:1to 10:1 (enhanced force: initial force), more typically from 2:1 to 5:1.In another aspect, the mechanical advantage is applied in a non-constantmanner such as progressive increase or progressive decrease ofmechanical advantage over the applied force cycle. The exact profile ofmechanical advantage variation may be readily determined by reference tothe desired spray profile and all relevant characteristics of the deviceand formulation to be sprayed (e.g. viscosity and density).

Suitably, the finger operable means has a form, which naturally givesrise to mechanical advantage such as a lever, cam or screw form.

The finger operable means may comprise of at least one lever pivotallyconnected to part of the housing and arranged to transfer force to thecontainer (e.g. acting directly thereupon) so as to urge the containertowards the nozzle when the or each lever is moved by a user.

In one aspect, there are two opposing levers, each of which pivotallyconnect to part of the housing and may be arranged to act upon thecontainer so as to urge the container towards the nozzle when the twolevers are squeezed together by a user.

Alternatively, the finger operable means may comprise of at least onelever to apply a force to an actuating means used to move the containertowards the nozzle so as to actuate the pump.

In which case the or each lever may be pivotally supported at a lowerend within the housing and the actuating means may in aspects beconnected to a neck of the container (e.g. formed as a collar thereto).

Suitably, there may be two opposing levers, each of which is pivotallysupported near a lower end of the housing and may be arranged to actupon the actuating means so as to urge the container towards the nozzlewhen the two levers are squeezed together by a user.

Alternatively, the finger operable means may comprise of at least onelever slidably supported within the housing to apply a force to thecontainer so as to move the container towards the nozzle and actuate thecompression pump.

Suitably, the fluid dispensing device further comprises a lock forreversibly locking the finger operable means to prevent unintendedmovement thereof.

The lock may comprise any suitable locking means, but is preferably ofrelatively simple form. Suitably, the lock comprises a mechanicallocking element such as a tab, clip, lug or peg.

In one aspect, the locking element is engageable with both the housingand the finger operable means to prevent relative movement therebetween. Suitably, the locking element engages with a locking portion ofthe housing and finger operable means such as a recess or apertureprovided thereto.

In one particular aspect, the locking element is provided to aprotective end cap reversibly receivable by the housing to reversiblycover the nozzle. Suitably, the locking element protrudes from the cap(e.g. taking the form of a tab, clip, lug or peg provided thereto) suchthat when the cap is received by the housing the locking element engageswith the housing and finger operable means to prevent relative movementthere between, but when the cap is removed from the housing (i.e. nozzleuncovered position) the locking element is also removed from engagementwith at least one of, preferably both of, the housing and fingeroperable means.

In another aspect, the locking element is provided to the housing and isengageable with the finger operable means to prevent relative movementthere between. Suitably, the locking element engages with a lockingportion of the finger operable means such as a recess or apertureprovided thereto.

In another aspect, the locking element is provided to the fingeroperable means and is engageable with the housing to prevent relativemovement there between. Suitably, the locking element engages with alocking portion of the housing such as a recess or aperture providedthereto.

Suitably, a pre-load means is provided to prevent actuation of thecompression pump until a pre-determined force is applied to the fingeroperable means. The pre-load means acts such as to prevent actuation ofthe compression pump until a pre-determined force is applied to thefinger operable means. The pre-determined force may thus, be thought ofas a ‘threshold’ or ‘barrier’ force which must first be overcome beforeactuation of the compression pump can occur.

The quantum of pre-determined force that is to be overcome beforeactuation of the compression pump is enabled is selected according tovarious factors including characteristics of the pump, typical userprofile, nature of the fluid and the desired spray characteristics.

Typically, the pre-determined force is in the range from 5 to 30N, moretypically from 10 to 25N. That is to say, typically from 5 to 30N, moretypically from 10 to 25N of force must be applied to the finger operablemeans before actuation of the compression pump is enabled. Such valuestend to correspond to a force which prevents a suitable ‘barrier force’to a weak, nondescript or unintended finger movement whilst readilybeing overcome by the determined finger (or thumb) action of a user. Itwill be appreciated that if the device is designed for use by a child orelderly patient it may have a lower pre-determined force than thatdesigned for adult usage.

In one aspect, the pre-load means is physically interposed between theor each finger operable means (e.g. lever) and the container.

In which case, the pre-load means may comprise of a step formed on thecontainer which must be ridden over by the or each lever before thecompression pump can be actuated wherein the step is over-ridden whenthe pre-determined force is applied to the or each lever.

Alternatively, the pre-load means may comprise of a step formed on theor each finger operable means (e.g. lever) which must be ridden over bythe container before the compression pump can be actuated wherein thestep is over-ridden when the pre-determined force is applied to the oreach lever.

In yet a further alternative, the pre-load means may comprise of atleast one detent formed on one of the container or the or each fingeroperable means (e.g. a lever) and a recess formed on the other of thecontainer or the or each lever wherein the or each detent is able toride out of the recess with which it is engaged when the pre-determinedforce is applied to the or each lever.

In another aspect, the pre-load means is interposed between the housingand the container.

In which case, the pre-load means may comprise of one or more detentsformed on the container for engagement with part of the housing, the orall of the detents being disengageable from the housing when thepre-determined force is applied to the finger operable means so as toallow the compression pump to be actuated.

Alternatively, the pre-load means may comprise of one or more detentsformed on the housing for engagement with part of the container, the orall of the detents being disengageable from the container when thepre-determined force is applied to the finger operable means so as toallow the compression pump to be actuated.

In another aspect, the pre-load means is interposed between thecontainer and the discharge tube.

In which case, the pre-load means may comprises of a step formed on thedischarge tube and at least one latching member attached to thecontainer, the arrangement being such that, when the pre-determinedforce is applied to the finger operable means, the or each latchingmember is able to ride over the step so as to allow the compression pumpto be actuated.

Alternatively, the pre-load means may comprise of a recess formed on thedischarge tube and at least one latching member attached to thecontainer, the arrangement being such that, when the pre-determinedforce is applied to the finger operable means, the or each latchingmember is able to ride out of the recess so as to allow the compressionpump to be actuated.

In another aspect, the pre-load means is interposed between the housingand the or each finger operable means (e.g. lever).

In which case, the pre-load means may comprise of at least one detentformed on the housing for engagement with each lever, the or all of thedetents being disengageable from the respective lever when thepre-determined force is applied to the or each lever so as to allow thecompression pump to be actuated.

Alternatively, the pre-load means may comprise of at least one detentformed on each lever for engagement with part of the housing, the or allof the detents being disengageable from the housing when thepre-determined force is applied to the or each lever so as to allow thecompression pump to be actuated.

In another aspect, the pre-load means is interposed between theactuating means and the housing.

In which case, the pre-load means may comprise of at least one detentformed on part of the actuating means for engagement with part of thehousing, the or all of the detents being disengageable from the housingwhen the pre-determined force is applied to the or each finger operablemeans (e.g. lever) so as to allow the compression pump to be actuated.

Alternatively, the pre-load means may comprise of at least one detentformed on part of the housing each detent being arranged for engagementwith a complementary recess formed on part of the actuating means, eachdetent being disengageable from its respective recess when thepre-determined force is applied to the or each finger operable means(e.g. lever) so as to allow the compression pump to be actuated.

In another aspect, the pre-load means is interposed between the or eachfinger operable means (e.g. lever) and the respective actuating means.

In which case, the pre-load means may comprise of at least one detentformed on the or each lever for engagement with a respective recessformed on part of the actuating means, each detent being disengageablefrom its respective complementary recess when the pre-determined forceis applied to the lever so as to allow the compression pump to beactuated.

Alternatively, the pre-load means comprises of at least one detentformed on each actuating means for engagement with a recess formed on arespective lever, each detent being disengageable from its respectivecomplementary recess when the pre-determined force is applied to thelever so as to allow the compression pump to be actuated.

As yet a further alternative, the pre-load means may comprise of anactuating device having a variable mechanical ratio such that until thepre-determined force is applied to the or each finger operable means(e.g. a lever) no significant force is transferred to the containeralong the longitudinal axis.

The fluid dispensing device may alternatively comprise of a fingeroperable means in the form of a single lever and the pre-load means mayfurther comprise of a spring interposed between the lever and thecontainer, the spring being used to urge the is container towards thenozzle so as to actuate the compression pump.

In which case the spring may be compressed by movement of the leveruntil the pre-determined force is applied (i.e. by a combination ofuser-applied force and stored spring force), at which point thethreshold of the pre-load means used to prevent actuation of thecompression pump is overcome by the force being applied to the containersuch that the container moves rapidly towards the nozzle so as toactuate the compression pump.

Suitably, the fluid dispensing device is additionally provided withforce modifying means for modifying the force applied to the container.That is to say, means for modifying the force applied to (and therefore,ultimately acting on) the container compared to that force directlyapplied to the finger operable means by the user.

Suitably, the force modifying means acts such as to amplify the forceapplied (i.e. it comprises force amplifying means). The amplificationmay be provided in either a uniform manner such as by a constantamplification, for example by a ratio of from 1.5:1 to 10:1 (amplifiedforce: initial force; i.e. degree of amplification of from 1.5 to 10),more typically from 2:1 to 5:1. In another aspect, the amplification isapplied in a non-constant manner such as progressive increase orprogressive decrease of mechanical advantage over the applied forcecycle.

The exact profile of force modification may be readily determined byreference to the desired spray profile and all relevant characteristicsof the device and formulation to be sprayed (e.g. viscosity anddensity).

The force modifying means may in one aspect, be integral with the fingeroperable means. In this aspect, the force modifying means may comprisean aspect of the finger operable means shaped to give rise to amechanical advantage (e.g. a lever, cam or screw feature).

In another aspect, the force modifying means is located non-integralwith the finger operable means, and typically between the fingeroperable means and the container. Again this aspect, the force modifyingmeans may comprise an aspect of the finger operable means shaped to giverise to a mechanical advantage (e.g. a lever, cam or screw feature).

In one aspect, the force modifying means only acts (i.e. only acts tomodify the user applied force) once the pre-determined force has beenovercome. In preferred aspects, the modifying force acts such that oncethe pre-determined force has been overcome the force applied to thecontainer is either relatively constant or increases on a relativelyconstant basis.

In one particular aspect, the force modifying means additionallycomprises a stop feature, which acts to stop force being applied to thecontainer once either a particular maximum force is reached or moretypically, once the container has been moved a particular distance. Inone aspect, the stop functions to prevent excess force being applied tothe compression pump.

Suitably, the pump comprises a pre-compression pump, such as a VP3, VP7or modifications, model manufactured by Valois SA. Typically, suchpre-compression pumps are typically used with a bottle (glass orplastic) container capable of holding 8-50 ml of a formulation. Eachspray will typically deliver 25-150 μl, particularly 50-100 μl of such aformulation and the device is therefore typically capable of providingat least 50 (e.g. 60 or 100) metered doses.

Other suitable fluid discharge devices include those sold by ErichPfeiffer GmbH, Rexam-Sofab and Saint-Cobain Calmar GmbH.

According to another aspect of the invention there is provided a fluiddispensing apparatus for housing a fluid discharging device, the fluiddispensing apparatus comprising a body defining a cavity; and adispensing nozzle having a dispensing orifice, wherein the dispensingorifice of the dispensing nozzle is provided with a reversible stopper.

The fluid dispensing apparatus may further comprise an end cap forengagement with the body wherein the end cap includes a stopper. The endcap may take any of the forms previously described.

In one aspect, the fluid dispensing apparatus may be provided separatelyfrom the fluid discharging device. In another aspect, the fluiddispensing apparatus and fluid discharging device are provided as a kitof parts.

According to a further aspect of the present invention there is alsoprovided an end cap suitable for use with a dispensing device orapparatus herein, wherein the end cap includes a stopper for reversiblestoppering of a dispensing orifice of a dispensing nozzle of the deviceor apparatus. The end cap may take any of the forms previouslydescribed.

According to a further aspect of the present invention there is providedthe use of a stopper to reversibly stop up (e.g. plug or seal) thedispensing orifice of a dispensing nozzle of a dispensing device hereinto prevent drain back of delivered fluid from the dispensing nozzle (inparticular, from the area at the tip of the nozzle and generallyadjacent to the dispensing orifice).

The device and method herein are in particular, designed to preventdrain back at the dispensing orifice of the nozzle to the pump. Basedupon a shot volume (i.e. volume of fluid delivered in one actuation) of50 μl from a typical nasal medicament dispenser device, the device andmethod herein suitably reduce drain back such that any reduction in shotvolume related thereto is less than 3 μl, preferably less than 2 μl overa period of 14 days when stored at 25° C. and ambient pressure.

The invention will now be described further with reference to theaccompanying drawing in which:—

FIG. 1 is a cross-section through a first embodiment of a fluiddispensing device according to the invention in a stoppered state;

FIG. 2 is a front view of the fluid dispensing device shown in FIG. 1 ina closed or stored condition with the fluid dispensing device laid onone side;

FIG. 3 is an end view of the fluid dispensing device shown in FIG. 2 inthe direction of arrow ‘V’ on FIG. 2;

FIG. 4 is a cross-section similar to that shown in FIG. 1 but showingthe insertion of a fluid discharge device according to a second aspectof the invention into a housing assembly according to a third aspect ofthe invention;

FIG. 5 is a cross-section similar to that of FIG. 1 but showing thefluid dispensing device in an use, unstoppered state;

FIG. 6 is a pictorial representation as viewed from a front right handcorner of a second embodiment of a fluid dispensing device according tothe invention in a stored state with a protective end cap in place;

FIG. 7 is a view similar to that of FIG. 6 but viewed from a front lefthand corner showing the fluid dispensing device in a ready for use statewith the protective end cap removed;

FIG. 7 a is a scrap view of part of the fluid dispensing device shown inFIG. 7 showing a modification to the device;

FIG. 8 is an enlarged pictorial view from the front and above of a topportion of the fluid dispensing device shown in FIG. 7;

FIG. 8 a shows a cross-sectional view of the end cap of the fluiddispensing device of FIG. 8;

FIG. 9 is a pictorial view of a body member forming part of the fluiddispensing device shown in FIG. 7 in a pre-assembled condition;

FIG. 10 is a pictorial view of a cover member forming part of the fluiddispensing device shown in FIG. 7 in a pre-assembled condition;

FIG. 11 is a pictorial view of the body member shown in FIG. 9 in apartly assembled condition in which a fluid discharge device accordingto the second aspect of the invention has been inserted;

FIG. 12 is a cut-away sectional view of part of a third fluid dispensingdevice herein;

FIGS. 13 a to 13 c are sectional views of the detail of stoppered endcaps in variations of fluid dispensing devices herein;

FIG. 14 a is a cross-sectional detail view of the relation of an end capand stopper to a dispensing nozzle herein; FIG. 14 b is a perspectiveview of the stopper part of FIG. 14 b;

FIG. 15 is a cross-sectional, part-exploded detail view of the relationof an end cap, end cap top insert and stopper to a dispensing nozzleherein;

FIG. 16 is a cross-sectional detail view of the relation of another endcap, end cap top insert and stopper to a dispensing nozzle herein;

FIG. 17 is a cross-sectional detail view of the relation of another endcap and stopper to a dispensing nozzle herein;

FIG. 18 is a cross-sectional detail view of the relation of yet anotherend cap and stopper to a dispensing nozzle herein;

FIG. 19 is a cross-sectional detail view of the relation of yet anotherend cap and stopper to a dispensing nozzle herein;

FIG. 20 is a cross-sectional detail view of the relation of yet anotherend cap and stopper to a dispensing nozzle herein;

FIG. 21 is a cross-sectional detail view of the relation of yet anotherend cap and stopper to a dispensing nozzle herein;

FIG. 22 is a cross-sectional detail view of the relation of yet anotherend cap and stopper to a dispensing nozzle herein;

FIG. 23 is a sectional view of the detail of an interference fit end capin a variation of the fluid dispensing device herein; and

FIG. 24 a to 24 c respectively show side, sectional and part sectionalviews of a further dispensing device herein, and FIGS. 24 d and 24 eshow sectional enlarged views of parts thereof.

With reference to FIGS. 1 to 5 there is shown a first embodiment of afluid dispensing device 5 for spraying a fluid into a body cavitycomprising a housing 9, a nozzle 11 for insertion into a body cavity, afluid discharge device 8 moveably housed within the housing 9, the fluiddischarge device 9 comprising a container 30 for storing the fluid to bedispensed and a compression pump 29 having a suction inlet 32 locatedwithin the container 30 and a discharge outlet 31 for transferring fluidfrom the pump 29 to the nozzle 11 and finger operable means 20, 21 toapply a force to the container 30 to move the container 30 towards thenozzle 11 so as to actuate the pump 29. The finger operable means beingin the form of two opposing levers 20, 21 each of which is pivotallyconnected to part of the housing 9 and is arranged to act upon a baseportion 35 of the container 30 so as to urge the container 30 towardsthe nozzle 11 when the two levers 20, 21 are squeezed together by auser.

In more detail the fluid dispensing device 5 comprises of a plasticmoulded body 6 and the fluid discharge device 8 and further comprises ofa protective end cap 7 having an inner surface for engagement with thebody 6 to protect the dispensing nozzle 11.

The body 6 is made from a plastic material such as polypropylene anddefines a housing 9 and a dispensing nozzle 11 so that the housing 9 andthe nozzle 11 are made as a single plastic component.

The housing 9 defines a cavity 10 formed by a front wall 12, a rear wall13 and first and second end walls 14 a, 14 b. The dispensing nozzle 11is connected to one end of the housing 9, extends away from the housing9 and has an external tapering form. It will be appreciated that theshape of the housing need not be oval it could be cylindrical or anyother convenient shape.

At least one of the front wall 12 and the rear wall 13 has an aperture28 therein to view the level of the fluid in the container 30 and in theembodiment shown there are apertures 28 in the front and rear walls 12,and 13 to view the level of the fluid in the container 30.

The discharge outlet from the pump 29 is in the form of a tubulardelivery tube 31 and a tubular guide in the form of an outlet tube 16 isformed within the nozzle 11 to align and locate the delivery tube 31correctly with respect to the nozzle 11.

An annular abutment 17 is formed at the end of the outlet tube 16. Theannular abutment 17 defines the entry to a nozzle orifice 15 throughwhich fluid can be dispensed in use and is arranged for abutment with anend of the delivery tube 31.

In the stoppered (storage) state of FIG. 1, rubber hemispherical nozzlestopper end 60 is reversibly mounted on annular abutment 17 to seal thenozzle orifice 15.

The fluid discharge device 8 has a longitudinal axis X-X and each of thelevers 20, 21 has an abutment surface 22, 23 arranged at an angle θ tothe longitudinal axis X-X of the fluid discharge device 8 for abutmentagainst a base portion 35 of the container so as to convert a forceapplied to the levers 20, 21 substantially transversely to thelongitudinal axis X-X of the fluid discharge device 8 into a force alongthe longitudinal axis X-X of the fluid discharge device 8.

This arrangement allows a standard fluid discharge device to be usedwithout modification.

The nozzle 11 has a longitudinal axis Y-Y and the longitudinal axis X-Xof the fluid discharge device 8 is aligned with the longitudinal axisY-Y of the nozzle 11. This has the advantage that when the pump 29 isactuated the force applied to the tubular delivery tube 31 is along theaxis of the tubular delivery tube and no bending or deflection of thedelivery tube 31 will occur due to the applied force.

At least part of the surface of the base portion 35 of the container 30is inclined at an angle φ with respect to the longitudinal axis X-X ofthe fluid discharge device 8 so as to form an inclined surface, the oreach inclined surface being arranged to be acted upon by the levers 20,21 so as to convert a force applied to the levers 20, 21 substantiallytransversely to the longitudinal axis X-X of the fluid discharge device8 into a force along the longitudinal axis X-X of the fluid dischargedevice 8.

Although in the disclosed embodiment both the levers and the containerhave surfaces inclined to the longitudinal axis of the fluid dischargedevice and that in the disclosed embodiment the angle θ is approximatelyequal to the angle φ this need not be the case. Only the container orthe levers need have an inclined surface or some other arrangement toapply the force from the levers to the container could be used.

The base portion 35 of the container 30 has two inclined surfaces 37, 38each arranged for co-operation with a respective one of the levers 20,21.

However it will be appreciated that the inclined surface of the baseportion of the container could be a conical, frusto-conical or partspherical surface.

The inclined surface 37 is arranged to co-operate with the abutmentsurface 22 and the inclined surface 38 is arranged to co-operate withthe abutment surface 23.

The abutment surface 22 is formed by an edge of a web 24 formed as partof the lever 20 and the abutment surface 23 is formed by an edge of aweb 25 formed as part of the lever 21.

Each of the levers 20, 21 is pivotally connected to part of the housing9 by a respective living hinge. In the embodiment shown each of thelevers 20, 21 is pivotally connected to a respective one of the two sidewalls 14 a, 14 b by a respective living hinge 26, 27.

The fluid discharge device 8 is in most respects conventional and willonly be described briefly herein.

The fluid discharge device 8 has a hollow container 30 defining areservoir containing several doses of the fluid to be dispensed and acompression pump 29 attached to one end of the container 30.

The container 30 as shown is made from a translucent or transparentplastics material however it will be appreciate that it could be madefrom other translucent or transparent materials such as glass.

The container has two or more supports to allow the container to bestood up on the base portion 35 and as shown two supports 40, 41 aremoulded as an integral part of the container 30. These supports areuseful in that, because the base portion 35 is made up of two inclinedsurfaces 37, 38, it could not normally be stood up vertically. The pump29 includes a plunger (not shown) slidingly engaged within a pump casing34 which defines a chamber (not shown) sized to accommodate a singledose of fluid. The plunger is attached to the tubular delivery tube 31which is arranged to extend from one end of the pump 29 for co-operationwith the outlet tube 16 of the dispensing nozzle 11. The plungerincludes a piston (not shown) slidably supported in the chamber formedin the pump casing 34.

The fluid is discharged through a discharge channel defined by thetubular delivery tube 31 into the orifice 15 of the dispensing nozzle11.

The size of chamber is such that it accommodates a single dose of fluid,the diameter of the chamber and piston combined with the stroke of theplunger being such that a full stroke of the plunger in the chamber willproduce a change in volume equal to a single dose of fluid.

The pump casing 34 is connected to the container 30 such that when thepiston is moved by a return spring (not shown) into a start position anew dose of fluid is drawn into the cylinder via the suction inlet inthe form of a pick-up tube 32 from the container 30 ready for discharge.

The tapering form of the base portion 35 of the container 30 isadvantageous in that it allows the pick up tube 32 to collect, withoutspecial orientation of the container, more fluid than if a flat bottomedcontainer is used.

The end cap 7 is a tubular component which is closed at one end and hasa thin flexible side wall which defines a cavity into which the nozzle11 is engaged to protect the nozzle 11 from damage.

It is envisaged that the end cap may be attached to the body by aflexible strap or tether which could be moulded as part of the end capor the end cap and the body could be made as a single component.

Assembly and operation of the fluid dispensing device is as follows.

FIG. 4 shows the fluid dispensing device 5 in a partly assembled statein which the two levers 20, 21 have been moved into a loading positionto allow the fluid discharge device 8 to be inserted into the cavity 10in the housing 9. In the partly assembled state, the stopper end 60 hasbeen removed from the annular abutment end 17 of the nozzle 11 to unsealthe orifice 15.

From the position shown the fluid discharge device 8 is moved upwardlyuntil the delivery tube 31 fully engages with the outlet tube 16. Thetwo levers 20, 21 are then folded down into the position shown in FIG. 1such that end portions of the abutment surfaces 22, 23 abut gentlyagainst the inclined surfaces 37, 38 of the container 30. The levers 20,21 in this position are used to hold the fluid discharge device 8 withinthe housing 9.

If required the container 30 or the pump casing 34 could be slidablyengageable with one or more support structures (not shown) to assistwith the location and retention of the fluid discharge device 8 in thehousing 9.

As shown in FIG. 5, in use, the end stopper 60 is removed from theannular abutment end 17 of the nozzle 11 to unseal the orifice 15. Theend stopper 60 is shown in up-ended view in which inner cavity 62 may beseen. It will be appreciated that the cavity 62 is sized and shaped foreffective, snug receipt by the annular nozzle end to ensure good sealingof the orifice 15.

To enable dispensing of fluid, a user first grasps the fluid dispensingdevice 5 by the two levers 20, 21. Provided that only a light pressureis applied to the levers 20, 21 no fluid will be discharged and the useris able to manoeuvre the dispensing nozzle 11 of the fluid dispensingdevice 5 into the body orifice into which fluid is required to bedispensed. This is because of the presence of the pre-loading means.

If the user then squeezes the two levers 20, 21 together with increasingforce the interaction of the abutment surfaces 22, 23 with the inclinedsurfaces 37, 38 causes the container 30 to be moved towards the nozzle11 as indicated by the arrow ‘M’ on FIG. 5.

However, the abutment between the end of the delivery tube 31 and theannular abutment 17 will prevent movement of the delivery tube 31 in thesame direction. This effect of this is to cause the delivery tube 31 topush the plunger into the pump casing 34 thereby moving the piston ofthe pump in the cylinder. This movement causes fluid to be expelled fromthe cylinder into the delivery tube 31. The fluid forced into thedelivery tube is then transferred into the orifice 15 from where it isexpelled as a fine spray into the body orifice.

Upon releasing the pressure applied to the levers 20, 21 the deliverytube 31 is urged out of the pump casing by the internal return springand causes fluid to be drawn up the pick-up tube 32 to re-fill thecylinder.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two doses of fluid arenormally administered at a time.

After use, the end stopper 60 will be replaced on the annular end 17 ofthe nozzle 11 to seal the orifice 15 and prevent drain back of fluid tothe delivery tube 31.

When the container is empty a new fluid discharge device 8 is loadedinto the housing 9 thereby restoring the fluid dispensing device 5 intoa useable condition.

With reference to FIGS. 6 to 11 there is shown a second embodiment of afluid dispensing device for spraying a fluid into a body cavity which isin many respects similar to that previously described.

The fluid dispensing device 105 comprising a housing 109, a nozzle 111for insertion into a body cavity, a fluid discharge device 108 moveablyhoused within the housing 109, the fluid discharge device 108 comprisinga container 130 for storing the fluid to be dispensed and a compressionpump 129 having a suction inlet located within the container 130 and adischarge outlet for transferring fluid from the pump 129 to the nozzle111 and finger operable means 120, 121 to apply a force to the container130 to move the container 130 towards the nozzle 111 so as to actuatethe pump 129. The finger operable means is in the form of two opposinglevers 120, 121 each of which is pivotally connected to part of thehousing 109 and is arranged to act upon the container 130 so as to urgethe container 130 towards the nozzle 111 when the two levers 120, 121are squeezed together by a user.

In more detail, the housing 109 comprises of a plastic cover member 110and a plastic body member 106 both of which are moulded from a suitableplastic material such as polypropylene. It will be appreciated that theshape of the housing need not be oval it could be cylindrical or anyother convenient shape.

The nozzle 111 is formed as an integral part of the body member 106 andthe body member 106 is fastened within the cover member 110 so that thenozzle 111 projects from one end of the cover member 110. The outersurface or a part of the outer surface of the nozzle could be made froma soft-touch plastics material.

The cover member 110 comprises of two cover shells 118 a, 118 b joinedtogether at one end by an annular ring 119.

A protective end cap 107 for the nozzle 111 is connected to the annularring 119 such that the end cap 107, the annular ring 119 and the twocover shells 118 a, 118 b are made as a one piece plastic component. Theprotective end cap may be moulded and arranged so as to be biased to aclosed position or may alternatively be biased to an open position.

The protective end cap 107 has an inner surface for engagement with thebody 106 to protect the dispensing nozzle 111. Two detents 149 areprovided on the inner surface of the end cap 107 to releasably hold theend cap 107 in place when it is in its protective position. The end cap107 has a protruding stopper end 160 which has a convex, resilient end161 form arranged for sealing engagement with a recess 141 in the end ofthe nozzle 111 so as provide an essentially airtight seal to nozzleorifice 115 to prevent fluid drain back when the stopper end 160 is inplace.

FIG. 8 a shows a cross-sectional view of the end cap 107 with protrudingstopper end 160 having convex end 161 shaped for effective sealing.

Each of the cover shells 118 a and 118 b is of a semi-cylindrical shapeand has two longitudinal edges 112, an end edge 113 and two transverseedges 116. At least one longitudinal edge 112 of each cover shell 118 a,118 b has a recess 114 formed therein. The recesses 114 co-operate todefine a window 150 through which the level of the fluid in thecontainer 130 can be checked.

In the embodiment shown and described both longitudinal edges 112 ofeach cover shell 118 a, 118 b have a recess 114 formed therein and therecesses 114 co-operate to define two windows 150 on opposite sides ofthe housing 109 through which the level of the fluid in the container130 can be checked.

Each of the cover shells 118 a, 118 b has an aperture 145 a, 145 bformed therein from which, in use, a part of a respective one of thelevers 120, 121 projects. The part of each lever 120, 121 which projectsfrom the aperture 145 a, 145 b is a ribbed finger grip 146 formed at theopposite end of each lever 120, 121 from where it is hingedly connectedto the body member 106. A part of each lever and in particular thefinger grips may be moulded from a soft touch plastic material.

As is shown in FIG. 7 a the fluid dispensing device includes a means toprevent inadvertent movement of the two levers when not in use. Themeans is a portion of each cover member 118 a, 118 b which overlies anend portion of each lever 120, 121. More specifically, each of the covershells 118 a, 118 b extends around the base portion of the cover toprovide an overlying shield 200. The shields 200 act as a means toprevent inadvertent movement of the two levers 120, 121.

The advantage of this construction is that accidental operation of thedispensing device when it is carried in a bag or pocket or generally isless likely to occur because the bottom portions of the levers 120, 121are covered and specific finger pressure has to be applied. It will beappreciated that a physical locking mechanism could also oralternatively be provided to prevent accidental movement of the twolevers 120, 121.

The body member 106 is engaged with the annular ring 119 to fasten thecover member 110 to the body member 106. The body member 106 has acylindrical portion for engagement with the annular ring 119.

Two detents 143 are formed on the cylindrical portion and two legs 144are connected near to one end of the cylindrical portion. The detents143 are used to trap the annular ring 119 against the legs 144 andthereby form a snap connection used to fasten the body member 106 to thecover member 110. It will be appreciated that other forms of snapfastening means could be provided.

Each of the levers 120, 121 is pivotally connected to the body member106 by a living hinge 126, 127. The living hinges 126, 127 are formed atthe juncture of the levers 120, 121 with the legs 144.

However, it will be appreciated that the levers could alternatively bepivotally connected to the cover member by a living hinge and that ineither case the invention is not limited to the use of a living hingeother hinge mechanisms could be used. The discharge outlet from the pump129 is in the form of a tubular delivery tube (not shown) and a tubularguide in the form of an outlet tube (not shown) is formed within thenozzle 111 to align and locate the delivery tube correctly with respectto the nozzle 111.

An annular abutment is formed at the end of the outlet tube. The annularabutment defines the entry to an orifice 115 through which fluid canflow in use and is arranged for abutment with an end of the deliverytube.

The fluid discharge device 108 has a longitudinal axis Z-Z and each ofthe levers 120, 121 has an abutment surface 122 (only one of which isvisible in the Figures) arranged at an angle to the longitudinal axisZ-Z of the fluid discharge device 108 for abutment against a baseportion 135 of the container so as to convert a force applied to thelevers 120, 121 substantially transversely to the longitudinal axis Z-Zof the fluid discharge device 108 into a force along the longitudinalaxis Z-Z of the fluid discharge device 108.

This arrangement allows a standard fluid discharge device to be usedwithout modification.

The nozzle 111 has a longitudinal axis P-P and the longitudinal axis Z-Zof the fluid discharge device 108 is aligned with the longitudinal axisP-P of the nozzle 111. This has the advantage that when the pump 129 isactuated the force applied to the tubular delivery tube is along theaxis of the tubular delivery tube and no bending or deflection of thedelivery tube will occur due to the applied force.

At least part of the surface of the base portion 135 of the container130 is inclined at an angle with respect to the longitudinal axis Z-Z ofthe fluid discharge device 108 so as to form an inclined surface, the oreach inclined surface being arranged to be acted upon by the levers 120,121 so as to convert a force applied to the levers 120, 121substantially transversely to the longitudinal axis Z-Z of the fluiddischarge device 108 into a force along the longitudinal axis Z-Z of thefluid discharge device 108.

Although in the disclosed embodiment both the levers and the containerhave surfaces inclined to the longitudinal axis of the fluid dischargedevice this need not be the case. Only the container or the levers needhave an inclined surface or some other arrangement to apply the forcefrom the levers to the container could be used.

In accordance with this embodiment the base portion 135 of the containerhas a conical inclined surface 138 arranged for co-operation with thelevers 120, 121.

However, it will be appreciated that the inclined surface of the baseportion of the container could be a frusto-conical or part sphericalsurface or could be comprised of two separate inclined surfaces each forco-operation with a respective one of the levers.

The inclined surface 138 is arranged to co-operate with both abutmentsurfaces 122 of the levers 120, 121.

The fluid discharge device 108 is in most respects conventional and willonly be described briefly herein.

The fluid discharge device 108 has a hollow container 130 defining areservoir containing several doses of the fluid to be dispensed and acompression pump 129 attached to one end of the container 130.

The container 130 as shown is made from glass however it will beappreciated that it could be made from other translucent or transparentmaterials such as plastic. The pump 129 includes a plunger (not shown)slidingly engaged within a pump casing 134 which defines a chamber (notshown) sized to accommodate a single dose of fluid. The plunger isattached to the tubular delivery tube which is arranged to extend fromone end of the pump 129 for co-operation with the outlet tube of thedispensing nozzle 111. The plunger includes a piston (not shown)slidably supported in the chamber formed in the pump casing 134.

The fluid is discharged through a discharge channel defined by thetubular delivery tube into the orifice 115 of the dispensing nozzle 111.

The size of chamber is such that it accommodates a single dose of fluid,the diameter of the chamber and piston combined with the stroke of theplunger being such that a full stroke of the plunger in the chamber willproduce a change in volume equal to a single dose of fluid.

The pump casing 134 is connected to the container 130 such that when thepiston is moved by an internal return spring (not shown) into a startposition a new dose of fluid is drawn into the cylinder via the suctioninlet in the form of a pick-up tube from the container 130 ready fordischarge.

The conical form of the base portion 135 of the container 130 isparticularly advantageous in that it allows the pick up tube to collectmore fluid, without special orientation of the container, than if a flatbottomed container is used.

Assembly and operation of the fluid dispensing device is as follows.

The first stage of assembly is to position the levers 120, 121 in theposition shown in FIG. 9 and then insert the fluid discharge device 108into the body member 106.

This is done by engaging the pump casing 134 with a cylindrical bore inthe cylindrical portion of the body member 106 and engaging the deliverytube with the outlet tube such that an end of the delivery tube is inabutment with the annular abutment in the outlet tube. The engagement ofthe pump casing 134 with the cylindrical portion of the body member 106is such that the pump casing 134 is able to slide in the cylindricalbore when a force is applied to the container 130 but is grippedsufficiently to hold the fluid discharge device 108 in position.

FIG. 11 shows the fluid dispensing device 105 in a partly assembledstate after this initial assembly operation in which the fluid dischargedevice 108 has been inserted into the body member 106. The two levers120, 121 have been folded down from the position shown in FIG. 9 into aready for use position such that end portions of the abutment surfaces122 and in particular the ridges 170 are positioned adjacent to a sidewall of the container and near to the inclined conical surface 138 ofthe container 130.

To complete the assembly of the fluid dispensing device 105 thecylindrical portion of the body member 106 is inserted into the annularring 119 and the two parts are snapped together. The two cover shells118 a and 118 b are then folded down from the position shown in FIG. 10into the position shown in FIG. 6.

It will be appreciated that in the fully assembled state the stopper end160 of the end cap 107 is sealingly received by the recess 141 in theend of the nozzle 111 thereby providing an essentially airtight seal tonozzle orifice 115 to prevent fluid drain back when the stopper end 160is in place.

The abutting transverse edges 116 of the two cover shells 118 a and 118b include complementary detents (not shown) such that when the covershells 118 a, 118 b are pushed together the detents snap together tohold them in the position shown in FIGS. 6 and 7. As an additionalmeasure an adhesive backed label (not shown) can be applied across thejoint between the two cover shells 118 a and 118 b on the base on theassembled fluid dispensing device 105 to prevent the cover shells 118 a,118 b from accidentally snapping open but more importantly to provide anindication that the fluid dispensing device 105 has not been tamperedwith.

To use the fluid dispensing device 105 a user first has to remove theprotective cap 107 (as shown in FIG. 7) thereby unsealing the nozzleorifice 115 by removing the stopper end 160 from the nozzle recess 141.The user then grasps the fluid dispensing device 105 by the two levers120, 121 and in particular by the two ribbed finger grips 146.

Provided that only a light pressure is applied to the levers 120, 121 nofluid will be discharged and the user is able to manoeuvre thedispensing nozzle 111 of the fluid dispensing device 105 into a bodyorifice such as a nasal cavity into which fluid is required to bedispensed.

If the user then squeezes the two levers 120, 121 together withincreasing force the interaction of the abutment surfaces 122 upon theinclined conical surface 138 will then cause the container 130 to bemoved rapidly towards the nozzle 111.

However, because of the abutment between the end of the delivery tubeand the annular abutment movement of the delivery tube in the samedirection is prevented and therefore the delivery tube acts so as topush the plunger into the pump casing 134 thereby moving the piston ofthe pump in the cylinder. This causes fluid to be expelled from thecylinder into the delivery tube and then into the orifice 115 from whereit is expelled as a fine spray into the body orifice.

Upon releasing the pressure applied to the levers 120, 121 the deliverytube is urged out of the pump casing by the internal return spring andcauses fluid to be drawn up the pick-up tube to re-fill the cylinder.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two doses of fluid arenormally administered at a time.

When the container 130 is empty a new fluid discharge device 108 isloaded into the body member 106 thereby restoring the fluid dispensingdevice 105 into a useable condition.

With reference to FIG. 12 there is shown (in part cut-away form) a thirdembodiment of a fluid dispensing device for spraying a fluid into a bodycavity.

The fluid dispensing device 205 comprises a housing 209, a nozzle 211for insertion into a body cavity, a fluid discharge device 208 moveablyhoused within the housing 209, the fluid discharge device 208 (ofgenerally conventional form, as described previously) comprising acontainer 230 for storing the fluid to be dispensed and a compressionpump 229 having a suction inlet located within the container 230 and adischarge outlet for transferring fluid from the pump 229 to the nozzle211.

The discharge outlet from the pump 229 is in the form of a tubulardelivery tube 231 and a tubular guide in the form of an outlet tube 216is formed within the nozzle 211 to align and locate the delivery tube231 correctly with respect to the nozzle 211.

An annular abutment 217 is formed at the end of the outlet tube 216. Theannular abutment 217 defines the entry to the outlet tube 216 throughwhich in use, fluid can be delivered to the nozzle orifice and isarranged for abutment with a circular lip 232 of the pump 229.

The housing 209 comprises body member 206 moulded from a suitableplastic material such as polypropylene. It will be appreciated that theshape of the housing need not be oval it could be cylindrical or anyother convenient shape. The nozzle 211 is formed as an integral part ofthe body member 206. The outer surface or a part of the outer surface ofthe nozzle could be made from a soft-touch plastics material.

The device 205 is provided with a protective end cap 207 having an innersurface for engagement with the body 206 to protect the dispensingnozzle 211. The end cap 207 is pivotally mounted to the body 206 atpivot-point 252. Detent 249 is provided to the inner surface of the endcap 207 to releasably hold the end cap 207 in place when it is in itsprotective position. The inner surface of end cap 207 is furtherprovided with annular, protruding walls 264 for housing resilientstopper 260 (e.g. formed of rubber). When the end cap 207 is in thestorage position (as shown in FIG. 12) the stopper 260 sealingly engagesthe concave tip 213 of nozzle 211 such as provide an essentiallyairtight seal to nozzle orifice 215 to prevent fluid drain back downoutlet tube 216 when the stopper end 260 is in place.

FIGS. 13 a to 13 c show simplified representations of various endcap/stopper configurations suitable for use with any of the fluiddispensing devices described herein.

In each of the variations of FIGS. 13 a to 13 c, fluid dispensing device305 comprises a body 306 including a nozzle 311 formed as an integralpart thereof. The body 306 has a plastic end cap 307 mounted thereto.

In the variation of FIG. 13 a, the end cap 307 is reversibly pushmounted onto the body 306.

In the variation of FIG. 13 b, the end cap 307 joins to the body 306 atliving hinge point 352 such that the end cap 307 is hingedly moveablefrom a storage position in which the end cap 307 covers the nozzle 311to an in-use position in which the nozzle 311 is uncovered. Detent 349is provided to the inner surface of the end cap 307 to releasably holdthe end cap 307 in place when it is in its storage position.

In the variation of FIG. 13 c, the end cap 307 is snap-fit mounted tothe body 306 352 such that the end cap 307 is hingedly moveable from astorage position in which the end cap 307 covers the nozzle 311 to anin-use position in which the nozzle 311 is uncovered. Annular ringretainer 349 is provided to the inner surface of the end cap 307 forengagement with the annular upper lip 355 of the body 306 to releasablyhold the end cap 307 in place when it is in its storage position.

In each of the variations of FIGS. 13 a to 13 c, the body 306 and endcap 307 are suitably moulded from a suitable plastic material such aspolypropylene. The outer surface or a part of the outer surface of thenozzle 311 could be made from a soft-touch plastics material. The innersurface of end cap 307 is further provided with annular, protrudingwalls 364 for housing resilient stopper 360 (e.g. formed of rubber).When the end cap 307 is in the storage position (as shown in each ofFIGS. 13 a to 13 c) the stopper 360 sealingly engages the concave tip313 of nozzle 311 such as provide an essentially airtight seal to nozzleorifice 315 to prevent fluid drain back when the stopper end 360 is inplace.

Suitable stoppers 260, 360 shaped for retention within an inner wall264, 364 structure of a protective end cap 207, 307 (e.g. as shown inFIGS. 12 to 13 c) may be formed in a variety of ways. In one aspect, arubber disc-shaped stopper is stamped from a sheet of rubber. In anotheraspect, a disc-shaped stopper is moulded (e.g. by an injection mouldingprocess). In a further aspect, the protective end cap is moulded and thestopper is then moulded within the formed end cap (i.e. a ‘two shot’moulding process).

Other variations of stopper and end cap are shown in FIGS. 14 a to 22,in which only a top part of the nozzle end of the dispensing device isshown. It will be appreciated that each of these variations may beincorporated as alternatives in the dispensing devices alreadyillustrated and described.

In more detail, the stopper 460 of FIGS. 14 a and 14 b has a ‘bowlerhat’ form and comprises disc-shaped base 466 and hemispherical head 465formed of a resiliently compressible material. The end cap 407 for thedispensing orifice 415 of the nozzle 411 is further provided at itsinner surface with annular, protruding walls 464 for housing resilientstopper 460 in ‘bowler hat’ configuration. When the end cap 407 is inthe storage position (as shown in FIG. 14 a) the base 466 of the stopper460 sealingly engages the dispensing orifice 415 at the tip 413 ofnozzle 411 such as provide an essentially airtight seal to thedispensing orifice 415 to prevent fluid drain back when the stopper end460 is in place. In embodiments, either a chordal section is cut awayfrom the base 466 of the stopper or the base 466 is formed with such a‘cut away’ shape thereby providing a base 466 shaped to assist withready insertion of the stopper 460 into the annual protruding walls 464.

The stopper 560 of FIG. 15 is in the form of a ‘thin wall’ part of endcap 507. In more detail, the end cap 507 for the dispensing orifice 515of the nozzle 511 is provided at its inner surface with annular,protruding walls 564 supporting a relatively flexible, thin wall 560,which in use, functions as a stopper 560. When the end cap 507 is in thestorage position (as shown in FIG. 15) the lower surface of the thinwall stopper 560 sealingly engages the dispensing orifice 515 at the tip513 of nozzle 511 such as provide an essentially airtight seal to thedispensing orifice 515 to prevent fluid drain back when the thin wallstopper 560 part of the end cap 507 is in place. A plug insert 570 isalso provided to plug the cavity 572 defined by the annular, protrudingwalls 564 of the end cap and thereby to protect the thin wall stopper560 from damage.

The stopper 660 of FIG. 16 is a variation of that of FIG. 15. In moredetail, stopper 660 of FIG. 16 is in the form of a compressible ‘thinwalled’ part of end cap 607. In more detail, the end cap 607 for thedispensing orifice 615 of the nozzle 611 is provided at its innersurface with compressible, protruding annular walls 664 supporting aflexible, thin wall 660, which in use, functions as a stopper 660. Whenthe end cap 607 is in the storage position (as shown in FIG. 16) thelower surface of the thin wall stopper 660 sealingly engages thedispensing orifice 613 at the tip 615 of nozzle 611 such as provide anessentially airtight seal to the dispensing orifice 615 to prevent fluiddrain back when the thin wall stopper 660 part of the end cap 607 is inplace. The annular walls 664 are part-compressed when the stopper 660sealingly interacts with the tip 613 of the nozzle 611. A plug insert670 is also provided to plug the cavity 672 defined by the compressibleannular, protruding walls 664 of the end cap and thereby to protect thethin wall stopper 660 from damage.

In turn, the stopper 760 of FIG. 17 is a variation of that of FIG. 16.In more detail, stopper 760 of FIG. 16 is in the form of a compressible‘thin walled’ concertina part 761 provided to end cap 707. In moredetail, the end cap 707 for the dispensing orifice 715 of the nozzle 711is provided at its inner surface with compressible, protruding annularwalls 764 supporting a concertina part 761 which at its end has aflexible, thin wall 760 that in use, functions as a stopper 760. Whenthe end cap 707 is in the storage position (as shown in FIG. 17) thelower surface of the thin wall stopper 760 sealingly engages thedispensing orifice 713 at the tip 715 of nozzle 711 such as provide anessentially airtight seal to the dispensing orifice 715 to prevent fluiddrain back when the thin wall stopper 760 part of the end cap 707 is inplace. The concertina part 761 is part-compressed when the stopper 760sealingly interacts with the tip 713 of the nozzle 711.

FIGS. 18 and 19 both illustrate end caps with stoppers that aresusceptible to manufacture by ‘two shot moulding’ operations.

In more detail, the stopper 860 of FIG. 18 is formed of a resilientlycompressible material applied as a ‘second shot’ moulding to an end cap807 previously formed by a first moulding operation. The end cap 807 forthe dispensing orifice 815 of the nozzle 811 is provided at its innersurface with annular, protruding walls 864 that in part, define theshape of resilient stopper 860. When the end cap 807 is in the storageposition (as shown in FIG. 18) the base 866 of the stopper 860 sealinglyengages the dispensing orifice 815 at the tip 813 of nozzle 811 such asprovide an essentially airtight seal to the dispensing orifice 815 toprevent fluid drain back when the stopper 860 is in place.

The stopper 960 of FIG. 19 is also formed of a resiliently compressiblematerial applied as a ‘second shot’ moulding to an end cap 907previously formed by a first moulding operation, but the amount ofmaterial provided during the ‘second shot’ moulding operation is moreextensive. In more detail, the end cap 907 for the dispensing orifice915 of the nozzle 911 is provided at its inner surface with annular,protruding walls 964 that in part, define the shape of the mouldingwhich forms resilient stopper 960. That moulding also however, extendsdown part of the inner surface (right hand side, as shown) of the endcap 907 to form a hinge 980 attachment means that connects to the base919 of nozzle 911 at attachment point 982. It will therefore beappreciated that the end cap 907 is both attached to the nozzle 911 andhingedly moveable about hinge 980 from a storage position (nozzle 911covered) to an in-use position (nozzle 911 uncovered). When the end 907is in the storage position (as shown in FIG. 19) the base 966 of thestopper 960 sealingly engages the dispensing orifice 915 at the tip 913of nozzle 911 such as provide an essentially airtight seal to thedispensing orifice 915 to prevent fluid drain back when the stopper 960is in place.

Stopper 1060 of FIG. 20 may be seen to form an integral part of end cap1007. Dispensing nozzle 1011 is provided at its tip 1013 with a head1016 of relatively soft and compressible material in the form of a ringdefining a channel 1017 shaped for receipt of the base 1066 of thestopper 1060. When the end cap 1007 is in the storage position the base1066 of the stopper 1060 inserts into the channel 1017 defined by thesoft ring 1016 at the nozzle tip 1015 and sealingly engages thedispensing orifice 1015 at the tip 1013 of nozzle 1011 such as providean essentially airtight seal to the dispensing orifice 1015 to preventfluid drain back.

Stopper 1160 of FIG. 21 has ‘roller ball’ form. In more detail, end cap1107 for the dispensing orifice 1115 of the nozzle 1111 is furtherprovided at its inner surface with annular, protruding walls 1164provided with skirt 1165 for receipt by groove 1168 provided to theroller ball form resilient stopper 1160 such as to retain the stopper1160. When the end cap 1107 is in the storage position (as shown in FIG.21) the spherical base 1166 of the stopper 1160 sealingly engages thedispensing orifice 1113 at the tip 1115 of nozzle 1111 such as providean essentially airtight seal to the dispensing orifice 1115 to preventfluid drain back when the stopper 1160 is in place.

Stopper 1260 of FIG. 22 has a ‘concave hollow’ form and comprisesresiliently compressible material. In more detail, the end cap 1207 forthe dispensing orifice 1215 of the nozzle 1211 is provided at its innersurface with annular, protruding walls 1264 for housing resilientstopper 1260 as shown. When the end cap 1207 is in the storage position(as shown in FIG. 22) the concave base 1266 of the stopper 1260sealingly engages the dispensing orifice 1213 at the convex tip 1215 ofnozzle 1211 such as provide an essentially airtight seal to thedispensing orifice 1215 to prevent fluid drain back when the stopper1260 is in place. The end cap 1207 is also provided with hingeattachment means 1280 for hinged attachment to the body of a dispensingdevice (not shown).

FIG. 23 shows a simplified representation of an alternative end capsuitable for use with any of the fluid dispensing devices describedherein, in which fluid dispensing device 1305 comprises a body 1306including a nozzle 1311 formed as an integral part thereof. The body1306 has a plastic end cap 1307 mounted thereto. The end cap 1307 isreversibly push mounted onto the body 1306.

The body 1306 and end cap 1307 are suitably moulded from a plasticmaterial such as polypropylene. The outer surface or a part of the outersurface of the nozzle 1311 could be made from a soft-touch plasticsmaterial. The inner surface of end cap 1307 is further provided with anannular, protruding wall 1364 having a flexible rim 1365 shaped forinterference engagement in the storage position (as shown in FIG. 23)with the nozzle 1311 to thereby define a sealed cavity space 1360. Inthe storage position, the sealed cavity space 1360 acts by way of a‘reverse pressure effect’ to prevent fluid drain back at the nozzleorifice 1315.

It will be appreciated that the embodiment of FIG. 23 uses a ‘sealedcavity space’ adjacent to the dispensing orifice 1315 to prevent drainback as alternative to the use of a stopper seal. It can however, bedifficult to ensure the integrity of this ‘sealed cavity space’, whichdifficulty does not arise with the stopper approach.

With reference to FIGS. 24 a to 24 e there is shown a further embodimentof a fluid dispensing device for spraying a fluid into a body cavity,which is in many respects similar to that previously described.

The fluid dispensing device 1405 comprising a housing 1409, a nozzle1411 for insertion into a body cavity, a fluid discharge device 1408moveably housed within the housing 1409, the fluid discharge device 1408comprising a container 1430 for storing the fluid to be dispensed and acompression pump 1429 having a suction inlet located within thecontainer 1430 and a discharge outlet for transferring fluid from thepump 1429 to the nozzle 1411 and finger operable means 1420 to apply aforce to the container 1430 to move the container 1430 towards thenozzle 1411 so as to actuate the pump 1429. The finger operable means isin the form of a lever 1420 pivotally connected to part of the housing1409 and arranged to act upon the container 1430 so as to urge thecontainer 1430 towards the nozzle 1411 when lever 1420 is squeezedinwardly by a user. The body 1409 is also provided with a window 1450through which the level of the fluid in the container 1430 can bechecked.

The nozzle 1411 is formed as an integral part of the body member 1406and the body member 1406 is provided with a protective end cap 1407 forprotection of the nozzle 1411. The outer surface or a part of the outersurface of the nozzle could be made from a soft-touch plastics material.First and second lugs 1449 a, 1449 b project from the protective end cap1407 for receipt within suitably arranged channels provided within thebody 1406 such as to allow secure attachment of the end cap 1407 to thebody 1406. When so-received, first lug 1449 a further interferes withmovement of lever 1420 such as to prevent actuation (i.e. to lockmovement) of the lever 1420 when the end cap 1407 and lugs 1449 a, 1449b are in place (i.e. in the nozzle covered position).

The end cap 1407 also has a protruding stopper 1460 which has a convex,resilient end 1461 form arranged for sealing engagement with thedispensing orifice 1415 of the nozzle 1411 so as provide an essentiallyairtight seal to nozzle orifice 1415 to prevent fluid drain back whenthe stopper 1460 is in place.

The fluid discharge device 1408 has a longitudinal axis Z-Z and thelever 1420, has a guide surface in the form of a beak 1422 arranged forinteraction with a drive dog 1492 provided to a collar 1490 fixed aroundthe neck of the container 1430. It will be appreciated that sidewaysforce (i.e. substantially transversely to the longitudinal axis Z-Z ofthe fluid discharge device 1408) applied to the lever 1420 results inmovement of the dog 1492 along the guide surface defined by the beak1422 thereby resulting in upward movement (i.e. along the longitudinalaxis Z-Z) of the fluid discharge device 1408.

In a subtle aspect, the ramp form guide surface 1422 has a variablemechanical ratio arranged such that until a pre-determined force isapplied to the lever 1420 no significant force is transferred to thecontainer 1430.

In more detail, a first portion 1423 a of the ramp 1422 is inclined at alesser angle (e.g. approx 20°) to a longitudinal (i.e. vertical, asshown) axis of the fluid discharge device 1408 than is the remaininglength 1423 b (e.g. angle approx. 45°) of the beak 1422. Therefore whena force is initially applied to the lever 1420 it is appliedsubstantially normal to the longitudinal axis of the fluid dischargedevice 1408 and virtually no force is converted into a force along thelongitudinal axis of the fluid discharge device 1408 and so the staticfriction between the first portion 1423 a of the beak 1422 and the drivedog 1492 is sufficient to maintain the lever 1420, stationary. However,when a pre-determined load is applied to the lever 1420 the staticfriction is overcome and the dog 1492 is able to start moving along thefirst portion 1423 a of the cooperating beak 1422. When the dog 1492reaches the end of the first portion 1423 a, the change in inclinationof the surface with which the dog 1492 is cooperating in combinationwith the magnitude of the force being applied ensures that the dog 1490suddenly slides rapidly along the second portion 1423 b of thecooperating beak 1422 causing the container 1430 to be moved rapidlytowards the nozzle 1411 to actuate the compression pump.

This ensures that the pump is only actuated when sufficient force isbeing applied to guarantee the production of an effective spray.

To use the fluid dispensing device 1405 of FIGS. 24 a to 24 e a userfirst has to remove the protective cap 1407 thereby unsealing the nozzleorifice 1415 by removing the stopper end 1460 therefrom. The user thengrasps the fluid dispensing device 1405 and places a thumb on lever1420.

Provided that only a light pressure is applied to the lever 1420 nofluid will be discharged and the user is able to manoeuvre thedispensing nozzle 1411 of the fluid dispensing device 1405 into a bodyorifice such as a nasal cavity into which fluid is required to bedispensed.

If the user then squeezes the levers 1420 inwards with increasing forcethe threshold force defined by the interaction of dog 1492 with firstpart of guide surface 1423 a of the beak 1422 is overcome resulting inthe container 1430 being moved rapidly towards the nozzle 1411 toactuate the pump 1429 and dispense fluid to the dispensing orifice 1415.Upon release of the pressure applied to the lever 1420 the pump is resetby its internal return spring.

A fluid dispensing apparatus for housing a fluid discharging deviceforming a second aspect of the invention is also disclosed. The fluiddispensing apparatus is in all respects the same as the fluid dispensingdevice previously described with the exception that it does not containa fluid discharging device.

The fluid discharging apparatus therefore comprises of a body defining acavity; and a dispensing nozzle having a dispensing orifice, wherein thedispensing orifice of the dispensing nozzle is provided with areversibly mounted stopper, wherein, in use, a fluid discharging device(e.g. pump action fluid dispenser) is positioned within the cavity forco-operation the dispensing nozzle.

In aspects, the fluid dispensing apparatus further comprises an end capfor engagement with the body, the end cap being adapted to comprise astopper, as described previously.

It is envisaged that the fluid discharging apparatus could be sold as anitem into which a fluid discharging device is fitted by a user orpharmacist.

Administration of medicament may be indicated for the treatment of mild,moderate or severe acute or chronic symptoms or for prophylactictreatment. It will be appreciated that the precise dose administeredwill depend on the age and condition of the patient, the particularmedicament used and the frequency of administration and will ultimatelybe at the discretion of the attendant physician. When combinations ofmedicaments are employed the dose of each component of the combinationwill in general be that employed for each component when used alone.

Appropriate medicaments may thus be selected from, for example,analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl ormorphine; anginal preparations, e.g., diltiazem; antiallergics, e.g.,cromoglycate (eg as the sodium salt), ketotifen or nedocromil (eg as thesodium salt); antiinfectives e.g., cephalosporins, penicillins,streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti-inflammatories, e.g.,beclomethasone (eg as the dipropionate ester), fluticasone (eg as thepropionate ester), flunisolide, budesonide, rofleponide, mometasone (egas the furoate ester), ciclesonide, triamcinolone (eg as the acetonide),6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl)ester or 6α,9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; antitussives, e.g., noscapine;bronchodilators, e.g., albuterol (eg as free base or sulphate),salmeterol (eg as xinafoate), ephedrine, adrenaline, fenoterol (eg ashydrobromide), formoterol (eg as fumarate), isoprenaline,metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (eg asacetate), reproterol (eg as hydrochloride), rimiterol, terbutaline (egas sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;PDE4 inhibitors eg cilomilast or roflumilast; leukotriene antagonists egmontelukast, pranlukast and zafirlukast; [adenosine 2a agonists, eg2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate)]*; [α4 integrin inhibitors eg(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino]propanoicacid (e.g as free acid or potassium salt)]*, diuretics, e.g., amiloride;anticholinergics, e.g., ipratropium (eg as bromide), tiotropium,atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone orprednisolone; xanthines, e.g., aminophylline, choline theophyllinate,lysine theophyllinate or theophylline; therapeutic proteins andpeptides, e.g., insulin or glucagons. It will be clear to a personskilled in the art that, where appropriate, the medicaments may be usedin the form of salts, (e.g., as alkali metal or amine salts or as acidaddition salts) or as esters (e.g., lower alkyl esters) or as solvates(e.g., hydrates) to optimise the activity and/or stability of themedicament and/or to minimise the solubility of the medicament in thepropellant.

Preferably, the medicament is an anti-inflammatory compound for thetreatment of inflammatory disorders or diseases such as asthma andrhinitis.

In one aspect, the medicament is a glucocorticoid compound, which hasanti-inflammatory properties. One suitable glucocorticoid compound hasthe chemical name:6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester (fluticasone propionate). Another suitableglucocorticoid compound has the chemical name: 6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester. A further suitable glucocorticoid compoundhas the chemical name:6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioic acidS-fluoromethyl ester.

Other suitable anti-inflammatory compounds include NSAIDs e.g. PDE4inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase andelastase inhibitors, beta-2 integrin antagonists and adenosine 2aagonists.

The medicament is formulated as any suitable fluid formulation,particularly a solution (e.g. aqueous) formulation or a suspensionformulation, optionally containing other pharmaceutically acceptableadditive components.

Suitably, the fluid medicament formulation herein has a viscosity offrom 10 to 2000 mPa·s (10 to 2000 centipoise), particularly from 20 to1000 mPa·s (20 to 1000 centipoise), such as from 50 to 1000 mPa·s (50 to1000 centipoise) at 25° C.

Suitable formulations (e.g. solution or suspension) may be stabilised(e.g. using hydrochloric acid or sodium hydroxide) by appropriateselection of pH. Typically, the pH will be adjusted to between 4.5 and7.5, preferably between 5.0 and 7.0, especially around 6 to 6.5.

Suitable formulations (e.g. solution or suspension) may comprise one ormore excipients. By the term “excipient”, herein, is meant substantiallyinert materials that are nontoxic and do not interact with othercomponents of a composition in a deleterious manner including, but notlimited to, pharmaceutical grades of carbohydrates, organic andinorganic salts, polymers, amino acids, phospholipids, wetting agents,emulsifiers, surfactants, poloxamers, pluronics, and ion exchangeresins, and combinations thereof.

Suitable carbohydrates include monosaccharides include fructose;disaccharides, such as, but not limited to lactose, and combinations andderivatives thereof; polysaccharides, such as, but not limited to,cellulose and combinations and derivatives thereof; oligosaccharides,such as, but not limited to, dextrins, and combinations and derivativesthereof; polyols, such as but not limited to sorbitol, and combinationsand derivatives thereof.

Suitable organic and inorganic salts include sodium or calciumphosphates, magnesium stearate, and combinations and derivativesthereof.

Suitable polymers include natural biodegradable protein polymers,including, but not limited to, gelatin and combinations and derivativesthereof; natural biodegradable polysaccharide polymers, including, butnot limited to, chitin and starch, crosslinked starch and combinationsand derivatives thereof; semisynthetic biodegradable polymers,including, but not limited to, derivatives of chitosan; and syntheticbiodegradable polymers, including, but not limited to, polyethyleneglycols (PEG), polylactic acid (PLA), synthetic polymers including butnot limited to polyvinyl alcohol and combinations and derivativesthereof;

Suitable amino acids include non-polar amino acids, such as leucine andcombinations and derivatives thereof. Suitable phospholipids includelecithins and combinations and derivatives thereof.

Suitable wetting agents, surfactants and/or emulsifiers include gumacacia, cholesterol, fatty acids including combinations and derivativesthereof. Suitable poloxamers and/or Pluronics include poloxamer 188,Pluronic® F-108, and combinations and derivations thereof. Suitable ionexchange resins include amberlite IR120 and combinations and derivativesthereof; Suitable solution formulations may comprise a solubilisingagent such as a surfactant. Suitable surfactants includeα-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl)polymers including those of the Triton series e.g. Triton X-100, TritonX-114 and Triton X-305 in which the X number is broadly indicative ofthe average number of ethoxy repeating units in the polymer (typicallyaround 7-70, particularly around 7-30 especially around 7-10) and4-(1,1,3,3-tetramethylbutyl)phenol polymers with formaldehyde andoxirane such as those having a relative molecular weight of 3500-5000especially 4000-4700, particularly Tyloxapol. The surfactant istypically employed in a concentration of around 0.5-10%, preferablyaround 2-5% w/w based on weight of formulation.

Suitable solution formulations may also comprise hydroxyl containingorganic co-solvating agents include glycols such as polyethylene glycols(eg PEG 200) and propylene glycol; sugars such as dextrose; and ethanol.Dextrose and polyethylene glycol (eg PEG 200) are preferred,particularly dextrose. Propylene glycol is preferably used in an amountof no more than 20%, especially no more than 10% and is most preferablyavoided altogether. Ethanol is preferably avoided. The hydroxylcontaining organic co-solvating agents are typically employed at aconcentration of 0.1-20% e.g. 0.5-10%, e.g. around 1-5% w/w based onweight of formulation.

Suitable solution formulations may also comprise solublising agents suchas polysorbate, glycerine, benzyl alcohol, polyoxyethylene castor oilsderivatives, polyethylene glycol and polyoxyethylene alkyl ethers (e.g.Cremophors, Brij).

Suitable solution formulations may also comprise one or more of thefollowing components: viscosity enhancing agents; preservatives; andisotonicity adjusting agents.

Suitable viscosity enhancing agents include carboxymethylcellulose,veegum, tragacanth, bentonite, hydroxypropylmethylcellulose,hydroxypropylcellulose, hydroxyethylcellulose, poloxamers (eg. poloxamer407), polyethylene glycols, alginates xanthym gums, carageenans andcarbopols.

Suitable preservatives include quaternary ammonium compounds (e.g.benzalkonium chloride, benzethonium chloride, cetrimide andcetylpyridinium chloride), mercurial agents (e.g. phenylmercuricnitrate, phenylmercuric acetate and thimerosal), alcoholic agents (e.g.chlorobutanol, phenylethyl alcohol and benzyl alcohol), antibacterialesters (e.g. esters of para-hydroxybenzoic acid), chelating agents suchas disodium edetate (EDTA) and other anti-microbial agents such aschlorhexidine, chlorocresol, sorbic acid and its salts and polymyxin.

Suitable isotonicity adjusting agents act such as to achieve isotonicitywith body fluids (e.g. fluids of the nasal cavity), resulting in reducedlevels of irritancy associated with many nasal formulations. Examples ofsuitable isotonicity adjusting agents are sodium chloride, dextrose andcalcium chloride.

Suitable suspension formulations comprise an aqueous suspension ofparticulate medicament and optionally suspending agents, preservatives,wetting agents or isotonicity adjusting agents.

The particulate medicament suitably has a mass mean diameter (MMD) ofless than 20 μm, preferably between 0.5-10 μm, especially between 1-5μm. If particle size reduction is necessary, this may be achieved bytechniques such as micronisation and/or microfluidisation.

Suitable suspending agents include carboxymethylcellulose, veegum,tragacanth, bentonite, methylcellulose and polyethylene glycols.

Suitable wetting agents function to wet the particles of medicament tofacilitate dispersion thereof in the aqueous phase of the composition.Examples of wetting agents that can be used are fatty alcohols, estersand ethers. Preferably, the wetting agent is a hydrophilic, non-ionicsurfactant, most preferably polyoxyethylene (20) sorbitan monooleate(supplied as the branded product Polysorbate 80).

Suitable preservatives and isotonicity adjusting agents are as describedabove in relation to solution formulations.

The dispensing device herein is suitable for dispensing fluid medicamentformulations for the treatment of inflammatory and/or allergicconditions of the nasal passages such as rhinitis e.g. seasonal andperennial rhinitis as well as other local inflammatory conditions suchas asthma, COPD and dermatitis.

A suitable dosing regime would be for the patient to inhale slowlythrough the nose subsequent to the nasal cavity being cleared. Duringinhalation the formulation would be applied to one nostril while theother is manually compressed. This procedure would then be repeated forthe other nostril. Typically, one or two inhalations per nostril wouldbe administered by the above procedure up to three times each day,ideally once daily. Each dose, for example, may deliver 5 μg, 50 μg, 100μg, 200 μg or 250 μg of active medicament. The precise dosage is eitherknown or readily ascertainable by those skilled in the art.

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the following claims:

1. A fluid dispensing device comprising a body defining a cavity and adispensing nozzle having a dispensing orifice, a fluid dischargingdevice housed in the cavity, the fluid discharging device having ahollow casing defining a reservoir for containing a volume of fluid anda pump having a suction inlet extending within the hollow casing, thepump having a discharge outlet extending from a first end of the hollowcasing for co-operation with the dispensing nozzle to enable pumpeddelivery of fluid from the reservoir to the dispensing nozzle, whereinthe dispensing orifice of the dispensing nozzle is provided with areversible stopper.
 2. A fluid dispensing device according to claim 1,wherein the stopper is reversibly mountable to the tip of the dispensingnozzle.
 3. A fluid dispensing device according to claim 2, wherein thedispensing nozzle tip defines an essentially flat profile.
 4. A fluiddispensing device according to claim 2, wherein the dispensing nozzletip defines a well circumferential to the dispensing orifice.
 5. A fluiddispensing device according to claim 1, wherein the stopper locatesexterior to the dispensing nozzle.
 6. A fluid dispensing deviceaccording to claim 1, wherein the stopper is independent of the fluiddischarging device.
 7. A fluid dispensing device according to claim 1,wherein the stopper defines a curved profile for contact with thedispensing nozzle.
 8. A fluid dispensing device according to claim 7,wherein the stopper defines a concave or convex profile for contact withthe dispensing nozzle.
 9. A fluid dispensing device according to claim7, wherein the stopper defines a hemispherical profile for contact withthe dispensing nozzle.
 10. A fluid dispensing device according to claim9, wherein the stopper comprises a flat base and a hemispherical headfor contact with the dispensing nozzle.
 11. A fluid dispensing deviceaccording to claim 7, wherein the shape of the stopper inversely mirrorsthat of the dispensing nozzle tip.
 12. A fluid dispensing deviceaccording to claim 2, the dispensing nozzle tip of the dispensing nozzlecomprises a soft, compressible material.
 13. A fluid dispensing deviceaccording to claim 1, wherein the stopper comprises plastic material.14. A fluid dispensing device according to claim 1, wherein the stoppercomprises resilient material.
 15. A fluid dispensing device according toclaim 13, wherein the stopper comprises a synthetic or naturallyoccurring polymeric material.
 16. A fluid dispensing device according toclaim 15, wherein the stopper comprises an elastomeric material.
 17. Afluid dispensing device according to claim 16, wherein said elastomericmaterial is a Thermoplastic Elastomer (TPE) material.
 18. A fluiddispensing device according to claim 1, wherein the stopper comprises amaterial of hardness of from 30 to 40 Shore A.
 19. A fluid dispensingdevice according to claim 1, additionally comprising a protective endcap having an inner surface for engagement with the body, wherein theend cap is moveable from a first position in which it covers the nozzleto a second position in which the nozzle is uncovered.
 20. A fluiddispensing device according to claim 19, wherein the stopper locates onthe end cap such that when the end cap is in the first position thestopper contacts the dispensing nozzle to seal the dispensing nozzleorifice and in the second position the stopper is spaced from thedispensing nozzle.
 21. A fluid dispensing device according to claim 20,wherein in the first position the stopper experiences a compressiveforce such as to ensure sufficient sealing contact with the dispensingnozzle.
 22. A fluid dispensing device according to claim 21, wherein thecompressive force experienced by the stopper is greater than 1.5N.
 23. Afluid dispensing device according to claim 20, wherein the stopper formsan integral part of the end cap.
 24. A fluid dispensing device accordingto claim 20, wherein the stopper mounts to the end cap.
 25. A fluiddispensing device according to claim 24, wherein an inner part of theend cap is provided with an annular wall defining a cavity for receiptof the stopper as an insert thereto.
 26. A fluid dispensing deviceaccording to claim 25, wherein the stopper insert comprises a flat baseand a hemispherical head and said flat base is shaped for receipt bysaid cavity such that the hemispherical head faces outwards.
 27. A fluiddispensing device according to claim 25, wherein the end cap is formedas a moulding and the stopper insert is provided as a second mouldingthereto.
 28. A fluid dispensing device according to claim 25, whereinthe stopper insert has a concertina form such that it may readilycompress to accommodate the form of the dispensing nozzle.
 29. A fluiddispensing device according to claim 25, wherein the stopper insert hasa roller ball form and the annular wall is provided with a mounting tomount the roller ball within the cavity.
 30. A fluid dispensing deviceaccording to claim 20, wherein an inner part of the end cap is providedwith an annular wall having a thin end wall provided thereto to act asthe stopper.
 31. A fluid dispensing device according to claim 20,wherein the end is provided with one or more guide projections shapedfor receipt by apertures and/or channels defined by the body to alignthe end cap with the body.
 32. A fluid dispensing device according toclaim 31, wherein one or more guide projections retaining means forreversibly retaining the end cap to the body.
 33. A fluid dispensingdevice according to claim 1, wherein the end cap comprises a rigidmaterial.
 34. A fluid dispensing device according to claim 1, whereinthe fluid discharging device is moveably housed within the body, thefluid discharging device having a longitudinal axis and the fluiddispensing device is provided with finger operable means moveable withrespect to the longitudinal axis of the fluid discharging device toapply a force to the container to move the container along thelongitudinal axis towards the dispensing nozzle so as to actuate thepump.
 35. A fluid dispensing device according to claim 34, wherein thefinger operable means is arranged to apply mechanical advantage.
 36. Afluid dispensing device according to claim 34, wherein the fingeroperable means comprises at least one lever pivotally connected to partof the body and arranged to transfer force to the container so as tourge the container towards the dispensing nozzle when the or each leveris moved by a user.
 37. A fluid dispensing device according to claim 34,additionally comprising a lock for reversibly locking the fingeroperable means to prevent unintended movement thereof.
 38. A fluiddispensing device according to claim 37, wherein the lock comprises alocking element engageable with both the body and the finger operablemeans to prevent relative movement there between.
 39. A fluid dispensingdevice according to claim 38, wherein the locking element is provided tothe protective end cap.
 40. A fluid dispensing device according to claim34, wherein a pre-load means is provided to prevent actuation of thepump until a pre-determined force is applied to the finger operablemeans.
 41. A fluid dispensing device according to claim 40, wherein thepre-determined force is in the range from 5 to 30N.
 42. A fluiddispensing device according to claim 1, wherein the pump comprises apre-compression pump.
 43. A fluid dispensing device as claimed in claim1, wherein said reservoir contains a volume of fluid medicamentformulation.
 44. A fluid dispensing device as claimed in claim 43,wherein said fluid medicament formulation is in the form of a solutionformulation.
 45. A fluid dispensing device as claimed in claim 44,wherein said fluid medicament formulation is in the form of a suspensionformulation.
 46. A fluid dispensing device as claimed in claim 43,wherein the fluid medicament formulation comprises an anti-inflammatorymedicament compound.
 47. A fluid dispensing device as claimed in claim46, wherein said medicament compound is a glucocorticoid compound.
 48. Afluid dispensing device as claimed in claim 47, wherein saidglucocorticoid compound is selected from the group consisting of6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; 6α,9α-difluoro-17α-[(2furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17α-carbothioicacid S-fluoromethyl ester; and6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester.
 49. A fluid dispensing device as claimed inclaim 48, wherein said medicament compound is selected from the groupconsisting of PDE4 inhibitors, leukotriene antagonists, iNOS inhibitors,tryptase and elastase inhibitors, beta-2 integrin antagonists andadenosine 2a agonists.
 50. A fluid dispensing apparatus for housing afluid discharging device, the fluid dispensing apparatus comprising abody defining a cavity; and a dispensing nozzle having a dispensingorifice, wherein the dispensing orifice of the dispensing nozzle isprovided with a reversible stopper.
 51. A fluid dispensing apparatusaccording to claim 50, additionally comprising a protective end caphaving an inner surface for engagement with the body, wherein said endcap is moveable from a first position in which the end cap covers thenozzle to a second position in which the nozzle is uncovered.
 52. Afluid dispensing apparatus according to claim 51, wherein the stopperlocates on the end cap such that when the end cap is in the firstposition the stopper engages the dispensing nozzle to seal the nozzleorifice and in the second position the stopper is disengaged from thenozzle.
 53. Kit of parts comprising a fluid dispensing apparatusaccording to claim 50 and a fluid discharging device having a hollowcasing defining a reservoir for containing a volume of fluid and a pumphaving a suction inlet extending within the hollow casing, the pumphaving a discharge outlet extending from a first end of the hollowcasing for co-operation with the dispensing nozzle to enable pumpeddelivery of fluid from the reservoir to the dispensing nozzle.
 54. Anend cap for use with a fluid dispensing device according to claim 20,wherein the end cap includes a stopper for reversible stoppering of thedispensing orifice the fluid dispensing device.
 55. (canceled) 56.(canceled)